Quantia Ige
FDA 510(k) K050493 · Biokit, S.A.
510(k) numberK050493
Submission
- Device name
- Quantia Ige
- Applicant
- Biokit, S.A.
Barcelona, ES - Received
- February 28, 2005
- Decision date
- August 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Quantia Ige cleared by the FDA?
Quantia Ige (K050493) received a 510(k) decision of Substantially Equivalent on August 16, 2005, 169 days after the submission was received.
What is the product code of K050493?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.